Sepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis

Not Applicable

Completed

• Conditions: Sepsis
• Interventions: Device: Breath sample collection

• Registration Number: NCT03497182
• Lead Sponsor: Landon Pediatric Foundation

Brief Summary

Breath samples will be collected from patients suspected of sepsis/severe sepsis or septic shock according to hospital sepsis screening criteria in the Emergency Department.

Detailed Description

Breath samples will be collected from patients suspected of sepsis that meet the criteria in the hospital's Sepsis Patient Management Protocol for blood lactate point of care testing. The breath samples will be collected from the patient by the Respiratory Therapist (RT) at the time of blood sample collection for the blood lactate test.

The breath samples will be analyzed via gas chromatography-surface acoustic wave spectroscopy for detection of a pattern of volatile organic compounds (VOCs). Multivariate analysis will be performed on breath sample data to determine feasibility of associating a unique VOC pattern with septic/severe septic/septic shock patients.

Study Timeline

• Study Start: 2017-05-02
• Study First Submitted: 2018-04-06
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-13
• Primary Completion: 2018-10-06
• Study Completion: 2018-10-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-03
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• admitted to Emergency Department
• suspected of sepsis according to hospital screening criteria; point of care blood lactate test performed
• age 18 or older

Exclusion Criteria

• member of Vulnerable Patient Population
• unable to complete Patient Informed Consent process/document

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breath sample collection	Breath sample collection	-

Primary Outcome Measures

Name	Time	Method
Volatile Organic Compound (VOC) Pattern	five minutes	Detection of a unique pattern of Volatile Organic Compounds (VOCs) in the breath samples of patients confirmed as having sepsis/severe sepsis/septic shock differentiated from subjects confirmed as not septic.

Trial Locations

Locations (1)

Ventura County Medical Center; 🇺🇸 Ventura, California, United States